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1209340

Regenerative Processing Plant, LLC — FEI 3011320041

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 30, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Palm Harbor, FL (United States)

Facility

Other inspections at this facility

  • 1115241 (NAI Thu Dec 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026965 (NAI Mon Aug 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940246 (NAI Mon Aug 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145221 CFR 211.113(b)Validation lacking for sterile drug products
186821 CFR 211.94(b)Protection from external factors
187621 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data
356721 CFR 211.84(d)(2)Component identification test
434521 CFR 211.160(b)(1)Samples (various types) representative, identified properly
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.
435921 CFR 211.170(b)(1)Retention time of reserve samples, in general
437721 CFR 211.188(b)(3)Identification of each component or in-process material