NATCO Pharma Limited Kothur Village, Mahaboob Nagar District

Form 483 issued June 6, 2019 · Kothur, India

Inspection: Jun 3 – Jun 6, 2019
Investigator: Patric C. Klotzbuecher
Observations: 9
Pages: 11
FEI number: 3004540906

In short: On June 6, 2019, FDA issued a Form 483 with 9 observations to NATCO Pharma Limited Kothur Village, Mahaboob Nagar District in Kothur, Telangana (FEI 3004540906) after an inspection that ran Jun 3 – Jun 6, 2019. The investigator was Patric C. Klotzbuecher. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).

At a glance

Quality system and laboratory controls account for 6 of 9 observations.

Quality system4

Laboratory controls2

Facilities & equipment2

Production1

Most cited: 21 CFR 211.68(a) (2×)

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit…
02
21 CFR 211.180(e)(1)
Written procedures are not followed for evaluations conducted at least annually to review records associated with…
03
21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
04
21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…

5 more observations

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

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This inspection in context

The investigator

Patric C. Klotzbuecher

13 documents · 2014–2019

Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.

The firm

NATCO Pharma Limited Kothur Village, Mahaboob Nagar District history

All 7 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.68(a)

See how FDA wrote the same problem up elsewhere.

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Questions about this 483

What did FDA find at NATCO Pharma Limited Kothur Village, Mahaboob Nagar District?

FDA listed 9 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.

Who inspected NATCO Pharma Limited Kothur Village, Mahaboob Nagar District?

Patric C. Klotzbuecher is named on this Form 483, for the inspection of Jun 3 – Jun 6, 2019. Each investigator has a profile showing what they cite most.

When was NATCO Pharma Limited Kothur Village, Mahaboob Nagar District inspected by FDA?

The inspection ran Jun 3 – Jun 6, 2019, and the Form 483 is dated June 6, 2019.

How do I get the full Form 483 for NATCO Pharma Limited Kothur Village, Mahaboob Nagar District?

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