VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
December 1, 2018
Mr. Kris Kringle, Owner
Santa’s Workshop, LLC
1225 Santa Clause Way
North Pole, Arctic Circle
Dear Mr. Kringle:
The U.S. FDA inspected your manufacturing facility, Santa’s Workshop, LLC at
1225 Santa Claus Way, North Pole Arctic Circle, from April 2 to April 20, 2018.
This warning letter summarizes significant violations of CGMP regulations for finished product. See 21 CFR, parts 210 and 211. During our inspection, our investigators observed specific violations including, but not limited to, the following.
CGMP Violations
1. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a) and 211.28).
Many members of your Enterprise Labor Force (ELF) unit lacked sufficient prior experience for designing and assembling (b)(4). At the time of our inspection, no ELF members had received training on CGMPs, and most were unaware of their responsibilities in the areas of cleanliness and proper attire. Hands and faces were often coated with chocolate, and bells on hats and shoes prevented protective apparel from attaining a proper fit. More generally, factory staff demonstrated an undisciplined, almost gleeful disregard for quality procedures. On three separate occasions, at critical stages of the manufacturing process, floor workers erupted into spontaneous song and dance.
Your written response of May 18, 2018 is inadequate because it does not address these training and experience deficiencies. While endearing, the ability to “sit on a shelf” or “live in a hollow tree” does not constitute acceptable manufacturing experience. Candy coating does not qualify as protective covering. And sticking one’s hands in a nearby snowdrift is not a recognized sanitation procedure. “Pure as the driven snow” is not a thing. Especially with all those reindeer knocking about.
2. Your firm failed to maintain a system by which the distribution of each lot of product can be readily determined to facilitate its recall if necessary (21 CFR 211.150(b)).
Product distribution records were incomplete and, in the event of a recall, would be insufficient to identify all product recipients.
Your written response of May 18, 2018 is inadequate. Santa’s Own Procedures (SOPs) are insufficient to capture the information required to conduct a thorough recall. Mr. Kringle may well know which customers are naughty and which are nice -- who’s good, who’s bad, who’s sleeping, and who’s awake, but this information is not written down and, in the opinion of our investigators, would be of limited value if it were.
3. Your firm failed to store product at an appropriate temperature to ensure the identity, strength, quality, and purity of the products are not affected (21 CFR 211.142(b)).
Entire sections of the facility lacked effective air conditioning, resulting in destruction of all (b)(4) warehoused in two large storage rooms. A third inadequately cooled room was not in use, and except for some miscellaneous items – a couple hunks of coal, a corncob pipe, and a large, oddly sad puddle of water – the room was all but empty.
Your written response of May 18, 2108 was inadequate. FDA isn’t really sure what to do with “that old silk hat we found” in your response package.
4. Products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed (21 CFR 211.165(f)).
While not strictly a violation of 21 CFR 211.165(f), the rejection and quarantining procedures your firm follows for products that fail to meet established criteria is concerning. While it’s appropriate to reject a (b)(4) that swims, a (b)(4) with square wheels, a (b)(4) that shoots jelly, and a (b)(4) that rides an ostrich, exile to a remote island ruled by a flying lion is, in a word, extreme. Your firm also rejected and exiled a (b)(4)-in-a-box for what was almost certainly an easily remediated labeling problem; reprocessing would have been a more appropriate course of action. Also, we just have to know. Seriously. WHAT WAS WRONG WITH THE DOLLY???
5. Your firm failed to establish adequate acceptance criteria for sampling and testing necessary to assure that batches of product meet appropriate specifications as a condition of their approval and release (21 CFR 211.165(d)).
Sampling procedures consisted of pulling each finished batch of (b)(4) out of a hot oven, taking a few nibbles, and declaring it “Jingle-icious.” Testers would frequently adulterate samples by submersing and saturating them with milk. These procedures are totally without scientific rigor. Furthermore, sampling was not restricted to members of the Quality Control Unit, but was extended to the entire plant floor. At times, sampling frequency was so high that there was very little, if any, of (b)(4) left to distribute. (On a personal note, our investigators would like to express their appreciation for the opportunity to participate in the testing activity. All the batches they sampled exceeded the strictest statistical quality control criteria, excepting the fruitcake, which could have benefited from additional stability testing and an earlier expiry date.)
Conclusion
Violations in this letter are not intended as an all-inclusive list. Typically the manufacturer is responsible for investigating violations, determining their root causes, and preventing their recurrence. However, in this case we’re going to make an exception. Though your methods and procedures are unconventional and frequently out of compliance with regulations, they are not wholly without merit. Our investigators have never experienced such a high level of workplace morale -- some calling it “downright merry” – and believe it warrants further observation. Investigators have suggested a series of mutually consultative visits to your workshop. Music, dance, batch samples, reindeer games, and the occasional adulterated eggnog are highly encouraged.
Sincerely,
/S/
Holly Bush
Division Director/OPQO Division I
North Pole District Office
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