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Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal

Form 483 issued September 8, 2023 · Sangareddy, India

Inspection
Sep 4 – Sep 8, 2023
Observations
4
Pages
5
FEI number
3004378446

In short: On September 8, 2023, FDA issued a Form 483 with 4 observations to Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal in Sangareddy, Telangana (FEI 3004378446) after an inspection that ran Sep 4 – Sep 8, 2023. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).

At a glance

Laboratory controls and facilities & equipment account for 3 of 4 observations.

Laboratory controls2
Facilities & equipment1
Quality system1

Most cited: 21 CFR 211.160 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 211.160

    Laboratory data is not documented contemporaneously at…

  2. 02
    21 CFR 211.67

    Cleaning validation studies are deficient in…

  3. 03
    21 CFR 211.160

    Laboratory controls are not adequate for the determination of conformance…

  4. 04
    21 CFR 211.192

    Your complaint investigations are inadequate for reasons including but not limited to root cause evaluation, corrective…

The full 483

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This inspection in context

The firm

Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal history

All 4 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.160

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal?

FDA listed 4 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.

When was Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal inspected by FDA?

The inspection ran Sep 4 – Sep 8, 2023, and the Form 483 is dated September 8, 2023.

How do I get the full Form 483 for Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal?

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