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U.S. Department of Health and Human Services

Science & Research

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Volume IV - 14.7 Initial Observations

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Orientation and Training

Food and Drug Administration

DOCUMENT NO.:
IV-14
VERSION NO.: 1.5

Section 14 - Complaints & Tampering

EFFECTIVE DATE:
10-01-03
REVISED: 02-14-13

The observation process should proceed in a logical manner working inward from the external surfaces, only opening the product container after all external examinations are completed. Written and photodocumentation of the suspect product should be provided for the container (box, carton, package, wrapper, bottle, etc.) and any other sample related items. Photodocumentation may include the use of standard 35mm film photography, digital camera photography, computer-operated scanner, CCD cameras coupled to computer controlled image capture devices, and even radiography. Include a legible measurement scale (preferably metric units) in every photographic image (regardless of media). Examination may include visual observations using the unaided eye and closer examination using a hand lens, stereoscopic light microscopy (SLM) and/or compound light microscopy. The suspect sample should be examined by short-wavelength and long-wavelength ultra violet light and/or a variable frequency light source (e.g., Crimescope®) and all findings documented. 

Control samples should be processed by the same procedures used for the suspect sample; any discrepancies are noted and documented. Record the manufacturing code and any codes printed on the labels, containers, and closure systems for both the suspect and the control.

Any odors detected should be immediately investigated before proceeding in order to prevent exposure to toxic vapors or gases. (See Section 14.5, Safety).

Check for any surface anomalies such as punctures, tears, cuts, holes, slits, abrasions, etc. Thoroughly examine all container closure seams, folds, crimps, caps, tops, lids, liners, etc. and note any irregularities. Document the condition of tamper evident closures such as safety seals, tear away ring bottle caps, etc. Look for chips or cracks in glass and damaged threads on screw caps. Packaging joints and seams should be closely examined for excess glue, glue smears, glue tear pattern, multiple glue types, etc. Any extraneous surface marks in paint, ink, pencil, marker, scratches, etc., should be documented. Note any discoloration, dust, powders, crystals, debris, or leakage. Evaluate the product for color, clarity, fluidity, layering, clumping, marks, chips, stains, orientation (e.g., capsule parts askew, units out of place in a sectioned package) and foreign objects, etc.

The location of any unusual findings or foreign objects should be diagrammed and photo documented. Removal of any portion of the suspect sample should take place only after the initial observations and photodocumentation have been completed. Once photographed in situ, the object or questionable portion of the sample may be isolated for additional characterization and/or chemical analysis.

Analysis of any observable foreign objects, foreign material or observed non-homogeneity may include characterization and chemical analyses by computer assisted image analysis, scanning electron microscopy with energy dispersive x-ray analysis, polarized light microscopy, FT-IR or some other technique.