Anthem Biosciences Limited
Form 483 issued December 8, 2022 · Kanakapura Taluk, Ramanagara District, India
- Inspection
- Dec 2 – Dec 8, 2022
- Investigator
- Kellia N. Hicks
- Observations
- 5
- Pages
- 12
- FEI number
- 3013884349
In short: On December 8, 2022, FDA issued a Form 483 with 5 observations to Anthem Biosciences Limited in Kanakapura Taluk, Ramanagara District, Karnataka (FEI 3013884349) after an inspection that ran Dec 2 – Dec 8, 2022. The investigator was Kellia N. Hicks. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to thoroughly investigate any unexplained failures related to process, equipment, systems, and drug substances, and…
- 02
Failure of your quality unit to exercise its responsibility to ensure intermediates and APIs manufactured at…
- 03
Your firm failed to clean, maintain, and store equipment and utensils to prevent malfunctions or contamination…
- 04
Buildings used in the manufacture, processing, packing, or holding of a drug substance are not of…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAnthem Biosciences Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Anthem Biosciences Limited?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Anthem Biosciences Limited?
Kellia N. Hicks is named on this Form 483, for the inspection of Dec 2 – Dec 8, 2022. Each investigator has a profile showing what they cite most.
When was Anthem Biosciences Limited inspected by FDA?
The inspection ran Dec 2 – Dec 8, 2022, and the Form 483 is dated December 8, 2022.
How do I get the full Form 483 for Anthem Biosciences Limited?
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.