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FDA Inspection
•Packaging Group Corp•June 6, 2017

Packaging Group Corp – FDA Inspection, Jun 6, 2017

Record Details

This FDA Inspection record concerns Packaging Group Corp, with an inspection on June 6, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Packaging Group Corp
Inspection Date
June 6, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Constantin Y. Philopoulos
View Company Profile

ID · 9a718b50-04da-4e3c-8827-f3144c200236

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1013016
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

7
  1. 21 CFR 211.25(a)GMP Training Frequency
  2. 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
  3. 21 CFR 211.130(c)Lot or control number assigned
  4. 21 CFR 211.100(a)Absence of Written Procedures
  5. 21 CFR 211.192Investigations of discrepancies, failures
  6. 21 CFR 211.80(a)Written Procedures Not Followed
  7. 21 CFR 211.182Written records kept in individual logs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Packaging Group Corp

1
DateClassificationOfficeProject area
July 15, 2026Not classifiedDetroit District Office
Other documents for Packaging Group Corp
  • FDA Inspection 1297854 - 2026-07-15

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