FDA Intel

Brassica Pharma Pvt Ltd.

Form 483 issued January 19, 2024 · Thane, India

Inspection
Jan 15 – Jan 19, 2024
Investigators
Anastasia M. Shields· Justin A. Boyd
Observations
10
Pages
18
FEI number
3014129013

In short: On January 19, 2024, FDA issued a Form 483 with 10 observations to Brassica Pharma Pvt Ltd. in Thane, Maharashtra (FEI 3014129013) after an inspection that ran Jan 15 – Jan 19, 2024. The investigators were Anastasia M. Shields and Justin A. Boyd. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).

At a glance

Production and facilities & equipment account for 8 of 10 observations.

Production5
Facilities & equipment3
Laboratory controls2

Most cited: 21 CFR 211.113(b) (2×)

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.194(a)

    Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…

  2. 02
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…

  3. 03
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…

  4. 04
    21 CFR 211.42(c)(10)

    Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…

6 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Anastasia M. Shields

45 documents · 2016–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.

The firm

Brassica Pharma Pvt Ltd. history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Brassica Pharma Pvt Ltd.?

FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.

Who inspected Brassica Pharma Pvt Ltd.?

Anastasia M. Shields and Justin A. Boyd are named on this Form 483, for the inspection of Jan 15 – Jan 19, 2024. Each investigator has a profile showing what they cite most.

When was Brassica Pharma Pvt Ltd. inspected by FDA?

The inspection ran Jan 15 – Jan 19, 2024, and the Form 483 is dated January 19, 2024.

How do I get the full Form 483 for Brassica Pharma Pvt Ltd.?

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.

$99Get it free