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FDA Warning Letter Explorer
FDA warning letter · Biologics

Microvascular Tissue, 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 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, as required by 21 CFR 211.100(a).** You have not validated the manufacturing process for your product with respect to identity, strength, quality, and purity. For example:

Passage 2

Failure to conduct at least one test to verify the identity of each component of a drug product, using specific identity tests if they exist, as required by 21 CFR 211.84(d)(1).** Identity testing is not performed on each component used in the manufacturing of mVASC, for example **(b)(4)**.

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(f)(1)
  • 21 CFR 1271.3(d)
  • 21 CFR 1271.10(a)(1)
  • 21 CFR 1271.3(c)
  • 21 CFR 1271.2
  • 21 CFR 1271.20
  • 21 CFR 210
  • 21 CFR 211.100(a)
  • 21 CFR 211.84(d)(1)