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FDA Warning Letter Explorer
FDA warning letter · Biologics

Skye Biologics Holdings LLC

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. 21 CFR 211.100(a).** Specifically, your firm has not validated the manufacturing processes for your products with respect to identity, strength, quality, and purity.

Passage 2

Failure to perform appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms.21 CFR 211.165(b).** Specifically, you failed to perform endotoxin testing on final product batches. Such laboratory testing is necessary as your products are purported to be sterile.

Passage 3

Failure to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. 21 CFR 211.192.** For example, from January 2021 to August 2022, you failed to investigate three action-level excursions for environmental monitoring observed in the a septic processing area (e.g., laminar flow hoods).

Passage 4

Failure to prepare batch production and control records that document each significant step in the manufacture, processing, packing, or holding of your umbilical cord blood products. 21 CFR 211.188(b).** Specifically, your batch production records do not include documentation of the accomplishment of each significant step in the manufacture of your products or the person(s) performing each of those steps, for example:

Passage 5

Failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates. 21 CFR 211.166(a).** Specifically, your firm has assigned a five-year expiration date for your products without supporting data regarding the stability characteristics of the products.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 1271.10(a)
  • 21 CFR 1271
  • 21 CFR 1271.15
  • 21 CFR 1271.3(d)
  • 21 CFR 1271.10(a)(1)
  • 21 CFR 1271.3(f)(1)
  • 21 CFR 1271.3(c)
  • 21 CFR 1271.2
  • 21 CFR 210
  • 21 CFR 211.100(a)
  • 21 CFR 211.42(c)(10)(iv)
  • 21 CFR 211.113(b)
  • 21 CFR 211.160(b)
  • 21 CFR 211.165(b)
  • 21 CFR 211.192
  • 21 CFR 211.188(b)
  • 21 CFR 211.166(a)