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FDA Warning Letter Explorer
FDA warning letter · Biologics

BioLab Sciences, Inc.

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 appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes [21 CFR 211.113(b)].** For example:

Passage 2

Failure to establish and follow written procedures for cleaning and maintenance of equipment used in the manufacture, processing, packing, or holding of a drug product [ 21 CFR 211.67(b)].** For example:

Passage 3

Failure to establish and follow written procedures describing in sufficient detail the methods and materials used for sanitation [21 CFR 211.56(b)].** For example:

Passage 4

Failure to ensure that each lot of components, drug product containers, and closures are withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit [21 CFR 211.84].** For example:

Passage 5

Failure to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)].** Specifically, your firm has not validated the manufacturing processes for Fluid GF™, Restore GF™, Fluid Flow™, Amnio Restore™, **(b)(4)**, Stimuleyes™, MyOwnSkin™, and MySkinRestore™.

Passage 6

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 twelve-month expiration date to your amniotic fluid products and a 24-hour expiration date to your skin products without supporting data from stability testing.

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 1271.10(a)(2)
  • 21 CFR 1271.3(d)
  • 21 CFR 1271.20
  • 21 CFR 1271.10(a)(1)
  • 21 CFR 1271.3(f)(1)
  • 21 CFR 1271.3(c)
  • 21 CFR 1271.10(a)(3)
  • 21 CFR 210
  • 21 CFR 211.113(b)
  • 21 CFR 211.160(b)
  • 21 CFR 211.67(b)
  • 21 CFR 211.56(b)
  • 21 CFR 211.42(c)(10)(i)
  • 21 CFR 211.192
  • 21 CFR 211.84
  • 21 CFR 211.100(a)
  • 21 CFR 211.166(a)
  • 21 CFR 312