COOK BIOTECH INCORPORATED
Form 483 issued February 11, 2022 · West Lafayette, Indiana
- Investigator
- Muna Algharibeh
- Observations
- 4
- Pages
- 4
- FEI number
- 3005071685
In short: On February 11, 2022, FDA issued a Form 483 with 4 observations to COOK BIOTECH INCORPORATED in West Lafayette, Indiana (FEI 3005071685). The investigator was Muna Algharibeh. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy. In addition, written records of investigations…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Muna Algharibeh
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmCOOK BIOTECH INCORPORATED history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at COOK BIOTECH INCORPORATED?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected COOK BIOTECH INCORPORATED?
Muna Algharibeh is named on this Form 483. Each investigator has a profile showing what they cite most.
When was COOK BIOTECH INCORPORATED inspected by FDA?
This Form 483 is dated February 11, 2022.
How do I get the full Form 483 for COOK BIOTECH INCORPORATED?
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.