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FDA Inspection
•Bryant Ranch Prepack, Inc.•June 11, 2009

Bryant Ranch Prepack, Inc. – FDA Inspection, Jun 11, 2009

Record Details

This FDA Inspection record concerns Bryant Ranch Prepack, Inc., with an inspection on June 11, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Bryant Ranch Prepack, Inc.
Inspection Date
June 11, 2009
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 4df37127-3fb3-4030-9f26-5cd418c49539

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
590126
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

6
  1. 21 CFR 211.46(d)Penicillin air handling systems not kept separate
  2. 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
  3. 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
  4. 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
  5. 21 CFR 211.166(a)Lack of written stability program
  6. 21 CFR 211.52Washing and toilet facilities are deficient

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Bryant Ranch Prepack, Inc.

8
DateClassificationOfficeProject area
July 16, 2026Not classifiedLos Angeles District OfficeDrug Quality Assurance
January 25, 2024VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 17, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 18, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
December 15, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 8 other inspections on the company page
Other documents for Bryant Ranch Prepack, Inc.
  • FDA Inspection 1326578 - 2026-07-16
  • FDA Inspection 1228907 - 2024-01-25
  • FDA Inspection 1165537 - 2022-03-17
  • FDA Inspection 1110509 - 2019-11-18
  • FDA Inspection 995337 - 2016-12-15

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