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FDA Inspection
•Tarmac Products, Inc.•June 2, 2011

Tarmac Products, Inc. – FDA Inspection, Jun 2, 2011

Record Details

This FDA Inspection record concerns Tarmac Products, Inc., with an inspection on June 2, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Tarmac Products, Inc.
Inspection Date
June 2, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 85bd6af8-5360-455e-b10c-909f6a05961e

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
727476
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

17
  1. 21 CFR 211.170(a)Active ingredient retained sample kept
  2. 21 CFR 211.188Prepared for each batch, include complete information
  3. 21 CFR 211.196Distribution Record Requirements
  4. 21 CFR 211.142(b)Storage under appropriate conditions
  5. 21 CFR 211.137(a)Expiration date lacking
  6. 21 CFR 211.184(c)Individual inventory record
  7. 21 CFR 211.204Record information maintained
  8. 21 CFR 211.125(a)Strict control not exercised over labeling issued
  9. 21 CFR 211.165(a)Testing and release for distribution
  10. 21 CFR 211.22(a)Approve or reject components, products

Showing 10 of 17 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Tarmac Products, Inc.

9
DateClassificationOfficeProject area
February 6, 2026VAIFlorida District OfficeDrug Quality Assurance
November 4, 2025VAIFlorida District OfficeCompliance: Medical Devices
July 22, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 27, 2019OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 10, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 9 other inspections on the company page
Other documents for Tarmac Products, Inc.
  • FDA Inspection 1301824 - 2026-02-06
  • FDA Inspection 1283730 - 2025-11-04
  • FDA Inspection 1175141 - 2022-07-22
  • FDA Inspection 1102996 - 2019-09-27
  • FDA Inspection 1031226 - 2017-11-10

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