Birchwood Laboratories, LLC
Form 483 issued August 19, 2022 · Eden Prairie, Minnesota
- Inspection
- Aug 15 – Aug 19, 2022
- Investigator
- Joseph A. Piechocki
- Observations
- 4
- Pages
- 6
- FEI number
- 2182825
In short: On August 19, 2022, FDA issued a Form 483 with 4 observations to Birchwood Laboratories, LLC in Eden Prairie, Minnesota (FEI 2182825) after an inspection that ran Aug 15 – Aug 19, 2022. The investigator was Joseph A. Piechocki. Most observations concern facilities & equipment and quality system.
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmBirchwood Laboratories, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Birchwood Laboratories, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Birchwood Laboratories, LLC?
Joseph A. Piechocki is named on this Form 483, for the inspection of Aug 15 – Aug 19, 2022. Each investigator has a profile showing what they cite most.
When was Birchwood Laboratories, LLC inspected by FDA?
The inspection ran Aug 15 – Aug 19, 2022, and the Form 483 is dated August 19, 2022.
How do I get the full Form 483 for Birchwood Laboratories, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.